FDA 510(k) Application Details - K242167

Device Classification Name	Media,Coupling,Ultrasound   More FDA Info for this Device
510(K) Number	K242167
Device Name	Media,Coupling,Ultrasound
Applicant	Anhui Deepblue Medical Technology Co.,Ltd. No. 777 Jimingshan Road, High-Tech Development Zone Hefei 230088 CN Other 510(k) Applications for this Company
Contact	Fengling Chen Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	MUI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/24/2024
Decision Date	09/19/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review